(198 days)
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No
The summary describes a standard immunoassay for measuring free thyroxine and does not mention any AI or ML components. The performance studies focus on traditional analytical metrics like imprecision, correlation, and specificity.
No
The device is for in vitro diagnostic use, meaning it's used for diagnosis and not for direct treatment of disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for in vitro diagnostic use" and that "Measurements of free thyroxine are used in the diagnosis and treatment of thyroid diseases."
No
The device description clearly outlines a competitive immunoassay using direct, chemiluminescent technology with physical components like reagents, antibodies, and paramagnetic particles. This indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "for in vitro diagnostic use".
- Measurement of Analytes: The device is designed to quantitatively determine "free thyroxine (FT4) in serum or plasma". This is a measurement of a substance within a biological sample.
- Diagnosis and Treatment: The intended use also states that these measurements "are used in the diagnosis and treatment of thyroid diseases". This directly links the test results to clinical decision-making.
- Device Description: The description details a "competitive immunoassay using direct, chemiluminescent technology" which is a common method used in in vitro diagnostic tests to measure specific substances in biological samples.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, obtained from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The ADVIA Centaur FT4 Immunoassay is for in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in serum or plasma (heparinized or EDTA) using the ADVIA Centaur and ADVIA Centaur XP Systems. Measurements of free thyroxine are used in the diagnosis and treatment of thyroid diseases.
Product codes (comma separated list FDA assigned to the subject device)
CEC
Device Description
The ADVIA Centaur FT4 assay is a competitive immunoassay using direct, chemiluminescent technology. Free thyroxine in the patient sample competes with acridinium ester-labeled T4 in the Lite Reagent for a limited amount of biotinylated polyclonal rabbit anti-T4 antibody that is bound to avidin that is covalently coupled to paramagnetic particles in the Solid Phase. There is an inverse relationship between the concentration of free thyroxine in the sample and relative light units (chemiluminescence).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was demonstrated by testing several method performance characteristics including imprecision, method comparison, interfering substances, and specificity. The following tables summarize the precision (total), interfering substances, specificity, serum / plasma equivalency and method comparison results.
All of the evaluation studies gave acceptable results compared to the predicate device. These studies support that the ADVIA Centaur FT4 immunoassay is substantially equivalent to the ACS:180 FrT4 immunoassay that is currently marketed.
Imprecision:
ADVIA Centaur FT4:
Level (ng/dL): 0.37, Total CV (%): 11.2
Level (ng/dL): 0.71, Total CV (%): 4.85
Level (ng/dL): 1.31, Total CV (%): 3.98
Level (ng/dL): 3.35, Total CV (%): 4.07
Level (ng/dL): 5.32, Total CV (%): 4.02
Level (ng/dL): 9.68, Total CV (%): 6.53
ACS:180 FrT4:
Level (ng/dL): 0.58, Total CV (%): 4.86
Level (ng/dL): 1.42, Total CV (%): 1.92
Level (ng/dL): 3.37, Total CV (%): 3.55
Study #2 - Multiple reagent lots, multiple systems:
ADVIA Centaur FT4:
Level (ng/dL): 0.72, Total CV (%): 4.16
Level (ng/dL): 1.47, Total CV (%): 4.58
Level (ng/dL): 3.01, Total CV (%): 4.44
Specificity:
Cross Reactant: L-Triiodothyronine, % Cross Reactivity:
§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.
0
Koro167
510(k) Summary
AUG - 8 2008
| Submitter information
Contact person: | Philip Liu, Ph.D.
Manager, Regulatory Affairs & Compliance |
|-----------------------------------------------------|------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics
511 Benedict Avenue
Tarrytown, NY 10591 |
| Phone: | 914-524-2443
914-524-2500 (fax) |
| Date summary prepared: | July 10, 2008 |
| Device Trade or Proprietary Names: | ADVIA Centaur FT4 Immunoassay |
| Device Common/Usual Name or
Classification Name: | Free Thyroxine test system |
| Classification Number / Class: | 21CFR 862.1695 / Class II |
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K080167
Assay Predicate Device:
| Predicate Device | ||
|---|---|---|
| Device Name | ACS:180 Free T4 Assay | |
| Common name | ACS FrT4 | |
| 510(k) Number | K961510 | |
| Manufacturer | Siemens Healthcare Diagnostics | |
| (formerly Siemens Medical Solutions Diagnostics) |
Device Description:
The ADVIA Centaur FT4 assay is a competitive immunoassay using direct, chemiluminescent technology. Free thyroxine in the patient sample competes with acridinium ester-labeled T4 in the Lite Reagent for a limited amount of biotinylated polyclonal rabbit anti-T4 antibody that is bound to avidin that is covalently coupled to
1
paramagnetic particles in the Solid Phase. There is an inverse relationship between the concentration of free thyroxine in the sample and relative light units (chemiluminescence).
Statements of Intended Use:
The ADVIA Centaur FT4 Immunoassay is for in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in serum or plasma (heparinized or EDTA) using the ADVIA Centaur and ADVIA Centaur XP Systems. Measurements of free thyroxine are used in the diagnosis and treatment of thyroid diseases.
Comparisons to the Predicate Device:
Assay Similarities
| | ADVIA Centaur FT4 Assay
(new device) | ACS:180 FrT4 Assay
(predicate device) |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use in
the quantitative determination
of free thyroxine (FT4) in
serum or plasma | For in vitro diagnostic use in
the quantitative determination
of free thyroxine (FT4) in
serum |
| Assay Method | Competitive immunoassay | Competitive immunoassay |
| Detection | Chemiluminescence | Chemiluminescence |
| Assay Range | 0.1 - 12.0 ng/dL | 0.1 - 12.0 ng/dL |
| Calibrators | Calibrator A | Calibrator A |
| Calibration | 2 point | 2 point |
| Reagents | Two liquid reagents, ready to
use | Two liquid reagents, ready to
use |
| Lite Reagent | Acridium ester labeled T4 | Acridium ester labeled T4 |
| Expected
Values
(ng/dL) | Euthyroid 0.89 - 1.76
Hypothyroid 1.76 | Euthyroid 0.89 - 1.76
Hypothyroid 1.76 |
| Standardization | Internal Standard (USP) | Internal Standard (USP) |
Assay Differences
| | ADVIA Centaur FT4 Assay
(new device) | ACS:180 FrT4 Assay
(predicate device) |
|------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------|
| Specimen Type | Human serum or plasma
(heparinized or EDTA) | Human serum |
| Solid Phase
Reagent | Biotin-labeled polyclonal anti-
T4 bound to avidin
paramagnetic particles | Polyclonal anti-T4 bound to
paramagnetic particles |
Siemens Healthcare Diagnostics (formerly Siemens Medical Solutions Diagnostics) ADVIA Centaur Free T4 Premarket Notification 510(k) 510(k) Summary (Revised, July 2008)
2
Performance:
Substantial equivalence was demonstrated by testing several method performance characteristics including imprecision, method comparison, interfering substances, and specificity. The following tables summarize the precision (total), interfering substances, specificity, serum / plasma equivalency and method comparison results.
All of the evaluation studies gave acceptable results compared to the predicate device. These studies support that the ADVIA Centaur FT4 immunoassay is substantially equivalent to the ACS:180 FrT4 immunoassay that is currently marketed.
Imprecision
| ADVIA Centaur FT4 | ACS:180 FrT4 | ||
|---|---|---|---|
| Level (ng/dL) | Total CV (%) | Level (ng/dL) | Total CV (%) |
| 0.37 | 11.2 | 0.58 | 4.86 |
| 0.71 | 4.85 | -- | -- |
| 1.31 | 3.98 | 1.42 | 1.92 |
| 3.35 | 4.07 | 3.37 | 3.55 |
| 5.32 | 4.02 | -- | -- |
| 9.68 | 6.53 | -- | -- |
| ADVIA Centaur FT4 | |
|---|---|
| Level (ng/dL) | Total CV (%) |
| 0.72 | 4.16 |
| 1.47 | 4.58 |
| 3.01 | 4.44 |
Study #2 - Multiple reagent lots, multiple systems
Specificity
The cross-reactivity of the ADVIA Centaur FT4 assay with a substance can be expressed as the ratio of:
• the amount of T4 required to displace 50% of the maximally bound labeled T4 from the anti-T4 antibody,
- · the amount of the cross-reactant to give the same 50% displacement
| Cross Reactant | % Cross Reactivity |
|---|---|
| L-Triiodothyronine |